eArchives

The Electronic Trial Master File Management System (eTMF) is a secure and standardized file management solution designed for the life sciences and pharmaceutical industries. It enhances the timeliness, accuracy, and completeness of clinical trial documentation. As a cloud-based application, it supports the DIA reference model and complies with Good Clinical Practice (GCP) regulations, covering all stages of clinical trial document management, including generation, collection, approval, signing, archiving, and quality control.

eTMF aids clients in managing daily Standard Operating Procedure (SOP) documents and maintaining a constant state of audit readiness, significantly boosting the efficiency and quality of file management. It enhances the transparency of Trial Master File (TMF) quality by establishing standardized procedures for TMF management.

Key Features

• Abundant template resources, including standard TMF models and SOP models, which incorporate industry-standardized DIA eTMF RM V3.0 and ICH-GCP essential documents for rapid project creation of TMF indexes.
• A real-time archiving mechanism and monitoring system for efficient file collection and processing.
• Customized approval workflows that comply with various enterprise SOP requirements.
• Diverse statistical charts and plots for effective data visualization.